eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
OVERVIEW
The Quality and Compliance Specialist will support the Quality and Compliance team with day-to-day Quality and Compliance administrative needs. Common tasks will include scheduling of audits, managing responses and follow-up, maintenance of the Quality Management System related to SOPs and Work Instructions, and helping to ensure timely completion of other needed tasks.
KEY TASKS & RESPONSIBILITIES
- Serve as the lead in scheduling all client audit request and being the logistical point of contact, which will include facilitating follow-up and audit responses seeing the process to closure
- Serve as a document coordinator owning the maintenance of the Company Quality Management System ensuring all SOPs are approved and effective as required Perform routing day-to-day administrative operations.
- Supports quality metric compilation, analysis, trending, and reporting.
- Provide backup support as required to the overall Quality and Compliance team
- Other duties as assigned.
Education & Experience
- BS degree or job-related equivalency preferred
- 5 years of experience Quality, Compliance or similar administrative role working in a fast-paced working environment preferred
Professional Skills
- Excellent knowledge of English
- Working knowledge of Good Clinical Practice (GCP)
- Working knowledge of Corrective Action/Preventative Action practices, including root cause analysis and effective checks
- Strong understanding of business goals and standards for customer service
- Strong Presentation/Public Speaking skills
- Excellent decision-making skills
- Strong interpersonal and communication skills
- Team player and Collaborator that can handle multiple tasks simultaneously in a fast-growing company.
Technical Skills
- Strong time-management and organizational skills
- Electronic Quality Management System experience
- Problem-solving skills
- Critical-thinking skills
- Adaptable to change
- Attention to detail
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
